YY/T 1260-2015 Active Industry standards-Medicine

YY/T 1260-2015 Diagnostic kit for IgM antibody to hepatitis E virus(ELISA)

Publish Date: 2015-03-02 Implement Date: 2016-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1260-2015

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2015-03-02

Implement Date: 2016-01-01

Pages: 7 pages

Scope

This standard specifies the terms and definitions, classification, requirements, test methods, marking, labeling, user's manual, packaging, transportation, and storage of the IgM antibody detection kit for hepatitis E virus (enzyme-linked immunosorbent assay).
This standard applies to kits that use the principle of capture enzyme-linked immunosorbent assay, which consists of a microplate coated with monoclonal antibodies against human IgM (μ chain) and enzyme-labeled hepatitis E virus (HEV) antigens, as well as other reagents. Alternatively, kits that use the principle of indirect enzyme-linked immunosorbent assay, which consists of a microplate coated with HEV antigens and enzyme-labeled antibodies against human IgM and other reagents, can be used to detect IgM antibodies to HEV in human serum or plasma samples.